Senate Introduces Bill to Streamline Breakthrough Technologies

Senator Dan Coats (IN), a member of the Senate Finance Committee, introducedlegislation today entitled "The Ensuring Patient Access to Critical Breakthrough Products Act." The legislation is a companion to a bill introduced in the House last month, and it would establish a program to accelerate transitional coverage and payment for new technologies that offer breakthroughs for serious illnesses affecting Medicare beneficiaries.

According to Senator Coats, "This legislation would streamline the current process, allowing Medicare patients to receive new treatments while also ensuring proper safety and quality regulations are met." Currently, new technology is able to pass through the Food and Drug Administration's (FDA) expedited review program, but then it faces up to three years of navigating the coverage and reimbursement process established by the Centers for Medicare and Medicaid Services. This legislation would grant new treatments approved by FDA a three-year temporary coverage period during which the therapy would receive a guaranteed level of payment. CMS could specify what additional data would be needed to continue coverage after the three-year period under its statutory "reasonable and necessary" standard.

MDMA will continue to work with Congress to support this and other pieces of legislation that would bridge the gap between the regulatory and reimbursement pathways for medical technologies.